Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis

Study Purpose

Endocopic remission rates of moderate to severe ulcerative colitis are low. Biologics including Vedolizumab, infliximab, and adalimumab are effective in induction and maintainence of ulcerative colitis. The role of 5-ASA in promoting a higher rate of endocsopic remission is unclear. We aim to evaluate the efficacy of combination of 5-ASA and biologics in treating ulcerative colitis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients with moderate and severe ulcerative colitis; 2. Subjects were above 18 years old and below 80 years; 3. Indications of 5-ASA or biological treatment; 4. According to the clinical symptoms, ulcerative colitis was diagnosed by endoscopic changes, pathological manifestations. The disease activity of UC was assessed according to the modified Mayo scoring system (modified Mayo: 6~12 for patients with moderate to severe ulcerative colitis); 5. If the subject is a woman, a pregnancy test at baseline is needed to exclude pregnancy. Female patients must follow the contraceptive recommendations of the project; 6. Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.

Exclusion Criteria:

1. No indications of 5-ASA or biological treatment; 2. ulcerative colitis patients who had previously undergone a partial colectomy; 3. Patients who are unable to use 5-ASA for a long time; 4. Patients with severe, progressive, or uncontrolled kidney, liver, blood, or endocrine diseases or symptoms; 5. Presence of infected persons, Patients with a contraindication to the use of biological agents such as C. difficile infection or other intestinal pathogens, active tuberculosis or intestinal tuberculosis infection, human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C (defined as: ① HBV: hepatitis B surface antigen (HBs Ag) positive (+), Or patients with positive for hepatitis B core antibody (HBcAb) and the qualitative test results of HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) meet the detection criteria; ② HCV: Any patient with an anti-HCV antibody (HCV Ab) -positive patient with a detectable HCV ribonucleic acid (RNA); 6. Patients with a history of gastrointestinal dysplasia, or dysplasia on any biopsy performed on endoscopy, excluding low-grade dysplasia lesions; known history of lymphoproliferative disease (including lymphoma), or signs and symptoms (e. g., lymphadenopathy and / or splenomegaly); patients with current or previous malignancy; 7. Has been involved in other clinical studies.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05205603
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sixth Affiliated Hospital, Sun Yat-sen University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis, Efficacy, Self, Biologics, Mesalazine
Arms & Interventions

Arms

Placebo Comparator: Biologics group

Biologics including infliximab and vedolizumab. infliximab: 5mg/kg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 5mg/kg every 8 weeks. vedolizumab: 300mg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 300mg every 8 weeks.

Experimental: 5-ASA group

5-ASA combined with biologics (including infliximab and vedolizumab). infliximab: 5mg/kg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 5mg/kg every 8 weeks. vedolizumab: 300mg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 300mg every 8 weeks. mesalazine: at a dose of 4-6g/d systemic or topical therapy

Interventions

Drug: - Infliximab

Infliximab, 5mg/kg at week 0,2,6 and schedule administration at every 8 weeks

Drug: - Vedolizumab

Vedolizumab, 300mg at week 0,2,6 and schedule administration at every 8 weeks

Drug: - Mesalazine

Mesalazine, 4-6g/d, systemic and/or topical administration

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

People's Hospital of Chongqing, Chongqing, Chongqing, China

Status

Address

People's Hospital of Chongqing

Chongqing, Chongqing,

Site Contact

Hong Guo

zhimin@mail.sysu.edu.cn

13508389768

Guangzhou, Guangdong, China

Status

Address

the Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 501655

First People's Hospital of Foshan, Guangzhou, Guangdong, China

Status

Address

First People's Hospital of Foshan

Guangzhou, Guangdong,

Guangzhou Panyu Central Hospital, Guangzhou, Guangdong, China

Status

Address

Guangzhou Panyu Central Hospital

Guangzhou, Guangdong,

Guangzhou, Guangdong, China

Status

Address

Nanhai Hospital, Southern Medical University

Guangzhou, Guangdong,

Guangzhou, Guangdong, China

Status

Address

Shunde Hospital of Southern Medical University

Guangzhou, Guangdong,

Shantou, Guangdong, China

Status

Address

First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong,

Dalian, Liaoning, China

Status

Address

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning,

Site Contact

Xiaoying Feng

zhimin@mail.sysu.edu.cn

17709870699

Shengjing Hospital, Shenyang, Liaoning, China

Status

Address

Shengjing Hospital

Shenyang, Liaoning,

Tianjin, Tianjin, China

Status

Address

General Hospital of Tianjin Medical University

Tianjin, Tianjin,

Zhejiang University, Hanzhou, Zhejiang, China

Status

Address

Zhejiang University

Hanzhou, Zhejiang,

Site Contact

Yan Chen

zhimin@mail.sysu.edu.cn

13757118653

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